The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)
A randomized comparison of Coronary Stents according to Short or Prolonged durations of Dual Antiplatelet Therapy in patients with Acute Coronary Syndromes: a pre-specified analysis of the SMART-DATE trial
Woo Jin Jang1; Jin Bae Lee2; Young Bin Song3; Ki Hong Choi3; Seung-Hyuk Choi3; Woo Jung Chun4; Ju Hyeon Oh4; Ik Hyun Park4; Joon-Hyung Doh5; Jin-Ok Jeong6; Jong-Seon Park7; Hyeon-Cheol Gwon3; Joo-Yong Hahn3, M.D.;
1. Ewha Womans University College of medicine, Seoul Hospital, Seoul, Korea 2. Daegu Catholic University Medical Center, Daegu, Korea 3. Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea 4. Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea 5. Inje University Ilsan Paik Hospital, Goyang, Korea 6. Chungnam National University Hospital, Daejeon, Korea 7. Youngnam University Hospital, Daegu, Korea
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Aims: We sought to compare biodegradable-polymer biolimus-eluting stents(BP-BES) with durable-polymer everolimus-eluting(DP-EES) and zotarolimus-eluting stents(DP-ZES) in patients with acute coronary syndrome(ACS) according to different duration of dual antiplatelet therapy(DAPT).
Methods and Results: In the SMART-DATE trial, 2712 patients with ACS underwent randomization for allocation of DAPT (6-month [n=1357] or 12-month or longer [n=1355]) and type of stents (BP-BES [n=901]), DP-EES [n=904], or DP-ZES [n=907]). At 18 months, primary endpoint (a composite of cardiac death, myocardial infarction, or stent thrombosis) was 2.6% with BP-BES, 2.0% with DP-EES, and 2.1% with DP-ZES (HR 1.29, 95% CI 0.70-2.39, p=0.42 for BP-BES vs. DP-EES and HR 1.23, 95% CI 0.67-2.26, p=0.50 for BP-BES vs. DP-ZES). The treatment effect of BP-BES for the primary endpoint was consistent among patients receiving 6-month DAPT as well as those receiving 12-month or longer DAPT (BP-BES vs. DP-EES, pinteraction=0.48 and BP-BES vs. DP-ZES, pinteraction=0.87). After excluding 179 patients (101 in the BP-BES group) who did not receive allocated DES, per-protocol analysis showed similar results.
Conclusions: The risk of a composite of cardiac death, myocardial infarction, or stent thrombosis was not significantly different between patients receiving BP-BES vs. DP-EES or DP-ZES across short or prolonged duration of DAPT after ACS.